MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG QUADROX-I ADULT WITHOUT INTEGRATED FILTER; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HMO 70000-J

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 10/19/2015

Event Type  malfunction  

Manufacturer Narrative

November 13, 2015 11:06 am (gmt-5:00) added by (b)(6): (b)(4).The device has been requested but not yet returned.A supplemental medwatch will be submitted when additional information becomes available.

Event Description

Description from the customer report: "during priming, it was found that the priming solution was leaking from the luer lock (upper one on the blood outlet side).Changed to another closing caps such as 3 way cock instead of original closing cap, however, the leakage didn't stop.The customer replaced the oxygenator to another hmo70000, put on the closing caps, and then restarted priming." (b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) received the product for investigation.A visual inspection was performed.Thereby it was noticed, that a foreign 3-way stop cock was fixed on upper luer lock on blood outlet side.The original screw cap was not delivered.During visual inspection several cracks have been noticed at the upper luer lock on blood outlet side.Because of these cracks the cone was not able to seal tight.The leakage was most probable caused by cracks at the luer lock on upper blood outlet side.Therefore the reported failure could be confirmed.Investigation is still pending.A supplemental medwatch will be submitted as soon as further information becomes available.

Event Description

(b)(4).

Manufacturer Narrative

(b)(4).Maquet cardiopulmonary (b)(4) received the product for investigation.A visual inspection was performed.It was noted that a foreign 3-way stop cock was fixed on upper luer lock on blood outlet side.The original screw cap was not delivered.During visual inspection several cracks were noticed at the upper luer lock on blood outlet side.Because of these cracks the cone was not able to seal tight.The leakage was most probably caused by cracks at the luer lock on upper blood outlet side.Therefore the reported failure could be confirmed.For further investigation the device history record has been reviewed by the manufacturer.The product passed every production step and was not marked as scrap.No production parameters could be identified that would indicate a nonconformance during production, in regards to the reported failure.The most probable cause of the failures found is excessive physical force during transport.The data is also being handled through a designated maquet cardiopulmonary trending and applicable investigation process.If a trend occurs, it will be escalated to quality assurance management for review and determination if further investigation is necessary.Due to this no further investigation initiations will be completed at this time.

Event Description

(b)(4).

• Brand Name: QUADROX-I ADULT WITHOUT INTEGRATED FILTER
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; rastatt ; GM
• Manufacturer (Section G): BERND RAKOW; maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; 76437 rastatt 76437 ; 4972229321
• MDR Report Key: 5224569
• MDR Text Key: 31467355
• Report Number: 8010762-2015-01169
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K082117
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,u
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 10/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2016
• Device Model Number: HMO 70000-J
• Device Catalogue Number: 70104.8759
• Device Lot Number: 70101749
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 11/23/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/22/2015
• Initial Date FDA Received: 11/15/2015
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 12/18/2015; 02/19/2016
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2014
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1